A Comparison Between Two Post-operative Dressings
- Conditions
- Surgical Incision
- Interventions
- Device: DrySee® dressing with moisture detectionDevice: Tegaderm® + Pad transparent film dressing
- Registration Number
- NCT04888624
- Lead Sponsor
- SerenaGroup, Inc.
- Brief Summary
Surgical site infections are one of the leading causes of post-operative morbidity and mortality worldwide. The ideal post-operative dressing is impermeable and remains intact preventing contamination of the incision with microorganisms. In addition, it is often difficult for the patient to identify breaks in dressing integrity. This trial compares a post-operative dressing (DrySee® Inc. Houston Tx) with moisture detection allowing the patient to recognize when the dressing is compromised to a standard post-operative dressing (Tegaderm® + Pad, 3M, St. Paul, MN). The ideal dressing also allows the patient to shower without removing the dressing.
- Detailed Description
Healthy subjects drawn from the general population. will undergo a 1.5cm incision on the volar forearm of each arm. The incision will be closed with streriostrips. The subject's incisions will then be randomized to receive either a Tegaderm® + Pad transparent film dressing or DrySee® dressing with moisture detection. The incisions will be photographed three times per week. Data on dressing wear time, integrity and adverse events will be collected every two days in the clinic.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- At least 18 years old.
- Subject has read, understood, and signed approved consent, and is willing to participate and comply with the study procedures and requirements.
- Subject on an investigational drug or therapeutic device within 30 days of the study visit.
- Presence of a condition that PI considers will compromise the subject's ability to participate in the study.
- Known allergy to any of the dressings or their components.
- The subject has a history of excessive bleeding.
- The subject has a history of keloid formation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DrySee® dressing with moisture detection DrySee® dressing with moisture detection DrySee® dressing with moisture detection Tegaderm® + Pad transparent film dressing Tegaderm® + Pad transparent film dressing Tegaderm® + Pad transparent film dressing
- Primary Outcome Measures
Name Time Method A comparison of wear time between the two post-operative dressings under study. 6-weeks A comparison of wear time between the two post-operative dressings under study.
- Secondary Outcome Measures
Name Time Method A comparison of dressing integrity between the two dressings under study if the dressings remains intact at the treatment visits by visual assessment. 6-weeks A comparison of dressing integrity between the two dressings under study if the dressings remains intact at the treatment visits by visual assessment.
A comparison of adverse events between the two treatment arms. 6-weeks A comparison of adverse events between the two treatment arms.
The effectiveness of liquid indication in identifying dressing compromise by visual assessment 6-weeks The effectiveness of liquid indicator of the dressing turning blue
A comparison between the two dressings to maintain waterproof protection of the incision by visual assessment if there was a break in the dressing border. 6-weeks A comparison between the two dressings to maintain waterproof protection of the incision by visual assessment of if there was a break in the dressing border at each treatment visit.
Trial Locations
- Locations (1)
Serena Group Monroeville
🇺🇸Monroeville, Pennsylvania, United States